GRAFTON™ DBM

GUDID 00643169964938

DBM T42275INT 8MMX1CMX10CM 2 EA GRFTON S

MEDTRONIC SOFAMOR DANEK, INC.

Bone matrix implant, human-derived

• Primary Device ID: 00643169964938
• NIH Device Record Key: e6d8b8bc-831d-4359-8901-c425b4ff12cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GRAFTON™ DBM
• Version Model Number: T42275INT
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: true
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169964938 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051188

FDA Product Code

• MBP: Filler, bone void, osteoinduction (w/o human growth factor)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-13
• Device Publish Date: 2024-12-05

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

• 00643169571839 - RIALTO™ SI FUSION SYSTEM: 2025-05-16 DEVICE 74200001245 THREADED 12X45
• 00763000880101 - n/a: 2025-05-16 INSERTER 7967012 CP
• 00643169500365 - CD HORIZON® Growth Rod Conversion Set: 2025-05-13 CONNECTOR 811212GR 110MM TI 5.5MM ROD S
• 00763000878016 - n/a: 2025-05-13 RASP 6630919 PARALLEL 10MMX15MMX12MM
• 00763000878047 - n/a: 2025-05-13 RASP 6630916 PARALLEL 7MMX15MMX12MM
• 00763000891367 - CD Horizon™ ModuLeX™ Spinal System: 2025-05-13 SHANK 55900608510 ILIAC 8.5X110MM
• 00763000891381 - CD Horizon™ ModuLeX™ Spinal System: 2025-05-13 SHANK 55900608560 ILIAC 8.5X60MM
• 00763000280468 - CENTERPIECE™ Plate Fixation System: 2025-05-12 TRAY 8530107R CENTERPIECE INSTRUMENTS